Study Start-Up Manager (client dedicated - US)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What You Will Be Doing:
Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives
Manage and may lead functional and cross-functional internal teams
Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
Proactively identify and escalate issues that arise related to support functional deliverables.
Responsible for implementation of standards for designated functional areas.
Provide oversight and direction to team members for functional and study-related deliverables
Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
Responsible and may be accountable for all activities associated with Study Start Up. This may include: Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements
Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period
Building relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU
Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
Contributing to process and tool development to the support of the SSU team with day-to-day activities
Leading the preparation of study level essential document templates
Aiding in the preparation of content for Regulatory submissions
Supporting ICF negotiations and escalation
Review and Approval of IMP Release Packages
Your Profile:
BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience or advanced degree
Must have knowledge of clinical trial conduct, including, multi-center, global trials.
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
Requires proven project management skills and leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
Global Experience with site activation activities including submission requirements.
Fluent in English.
Minimal (10-15%) travel required
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
